Events

Recall of Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sunrise Medical Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00012-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00012-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Two reported incidences have occurred since the product was first released in december 2004, where the upper base casting has fractured. the looseness or removal of the four screws that locate the base plate to the upper base casting may allow the base casting to be distorted or weakened under load and possibly fracture if excessive force is applied.This recall action undertaken in february 2013 was carried out prior to the approval of the recall strategy by the tga.
  • Action
    Sunrise Medical is advising users that affected units will be upgraded as part of the next scheduled inspection. This action has bee closed-out on 12/02/2016.

Device

Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)
  • Model / Serial
    Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)ARTG Number: 101303
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd